We are happy to announce that our clinical study KH007 (NCT06219629) of Disease Progression in Parkinson’s Disease (PD) achieved the last patient in (LPI) on January 10, 2025. This is a multicenter, longitudinal, observational study to determine usability, validity, and reliability of digital assessments over a 12 month period amongst participants with PD. The main study objective is to evaluate compliance and usability of components of the Koneksa Neuroscience Toolkit, which includes both point-in-time task-based data collection and continuous monitoring by means of digital health technologies (DHTs). Additional objectives include assessing content validity, criterion validity, construct validity, and known group validity of the DHT-derived measures and the ability of these measures to detect change alongside expected disease progression. The DHT-derived measures were selected based on assessments included in the PD “gold standard” Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) that are amenable to remote digital data collection and are safe for patients to perform at home. Detecting changes in the disease course to assess therapeutic efficacy using MDS-UPDRS is challenging because this scale may not be sensitive enough to detect meaningful changes early in the disease, in addition to inherent variability among raters. DHT-derived data can collect information about key disease features (e.g. walking parameters, postural or kinematic tremor) by objective means – data collected by sensors embedded in smartphones or wearables can provide objective data and collected in a convenient fashion for patients under free living conditions. Moreover, the digital toolkit contains electronic patient outcome (ePRO) questionnaires that can elucidate further how people feel and how PD impacts their activities of daily living. The main aims of this clinical study are to obtain a granular view of disease progression with advanced digital measures, assess key validation parameters, and compare to healthy controls.
This Koneksa sponsored study is done in a curated collaboration with pharmaceutical partners, Merck and Regeneron. The syndication model used in this partnership combines the best features of a single organization sponsored study and a traditional precompetitive consortium initiative, enabling efficient protocol development with multi-stakeholder input and study execution done on a device agnostic platform. This data set will be extremely valuable to partners who will get insights for their development programs. We also believe that this is a great opportunity to collaborate and steward knowledge; we hope that other organizations with scientific interest in PD will join us.
Natural history studies evaluating technology performance can be difficult to recruit due to the lack of potential benefit of a therapeutic intervention, unlike a drug development study. The KH007 study started recruiting in February 2024, and we are proud to announce that study enrollment has been completed in less than 11 months. We are also pleased with the excellent conduct of the study and observed compliance with study procedures. We are deeply grateful to the PD participants who enrolled in our study and are contributing extremely valuable data; we appreciate all the clinical sites, investigators and staff driving operational excellence. The preliminary results will be announced at upcoming conferences in 2025.